Virtual Reality for Seniors Under Spinal Anesthesia

(SILVR Trial)

Not yet recruiting at 1 trial location

Overseen By Nadia Godin

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Epilepsy, Severe dizziness, Mental impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) can help seniors feel more comfortable during surgeries where they are awake but numb from the waist down (spinal anesthesia). The focus is on determining if VR enhances the surgery experience for elderly patients. Participants will wear a virtual reality headset (also known as VR Headset or Virtual Reality Distraction Therapy) to assess whether it makes the surgery more pleasant. The trial seeks individuals over 65 who plan to undergo surgery with spinal anesthesia and do not have issues such as hearing or vision problems, epilepsy, or recent facial surgeries. As an unphased trial, this study provides a unique opportunity to explore innovative ways to improve surgical experiences for seniors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality technique is safe for seniors under spinal anesthesia?

Research has shown that using virtual reality (VR) headsets during surgery is generally safe and can help reduce pain and anxiety in patients. In one study, adults using VR during minor procedures experienced no serious side effects. Another review found VR to be a helpful distraction during certain medical procedures with anesthesia.

While VR is not a medication, it offers a non-drug way to manage anxiety and pain. It has shown promise, especially for older adults during surgeries. So far, studies have not reported major safety concerns with its use in these situations.

Overall, VR appears well-tolerated and could offer a safe way to reduce surgical stress without needing extra medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for seniors undergoing spinal anesthesia because it offers a unique, non-drug method to potentially reduce anxiety and discomfort during procedures. Traditional approaches typically involve sedatives or anxiolytics, which can have side effects and might not be suitable for all elderly patients. VR provides an immersive experience that can distract and calm patients without the need for additional medication. This technology could lead to a more pleasant surgical experience and reduce the reliance on pharmaceuticals, making it a promising alternative in the medical field.

What evidence suggests that virtual reality is effective for seniors under spinal anesthesia?

This trial will evaluate the use of a Virtual Reality Headset for seniors undergoing surgeries with spinal anesthesia. Studies have shown that virtual reality (VR) can reduce pain and anxiety during medical procedures. Research indicates that using VR as a distraction during surgeries with anesthesia can lower the need for sedatives, which are drugs that help patients relax. In previous studies, patients reported greater satisfaction with their experience when VR was used. VR has been successfully used during various surgeries to enhance patient comfort. While this study focuses on seniors, the overall evidence supports VR's potential to improve the surgical experience for many patients. ^{2 3 5 6 7}

Who Is on the Research Team?

Pascal Laferrière-Langlois

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Are You a Good Fit for This Trial?

This trial is for patients over 65 years old who are having elective surgery with spinal anesthesia. They must be able to give consent and use their hands. It's not for those with severe mental issues, epilepsy, recent eye or facial surgeries, or hearing/vision problems.

Inclusion Criteria

I am over 65 years old and have given my full consent.

I am scheduled for surgery that will use spinal anesthesia.

Exclusion Criteria

Severe mental impairment

I cannot use my hands.

I have a history of epilepsy, seizures, or severe dizziness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Anxiety levels are assessed before surgery using the Amsterdam Preoperative Anxiety and Information Scale

2 hours

1 visit (in-person)

Intraoperative

Participants wear a virtual reality headset during surgery to evaluate tolerance and measure time worn

45 minutes

1 visit (in-person)

Postoperative

Patient satisfaction and ease of use of VR are assessed through semi-structured interviews

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and overall satisfaction after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Headset

Trial Overview The study tests the acceptability of using a virtual reality headset during surgery in seniors under spinal anesthesia. The goal is to see if VR can improve the surgical experience for elderly patients.

How Is the Trial Designed?

Group I: a group of 55 patients Experimental Treatment 1 Intervention

Virtual Reality Headset is already approved in United States for the following indications:

Approved in United States as Virtual Reality Headset for:

• Pain management
• Anxiety reduction

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06515873

Study Details | NCT06515873 | Seniors' Intraoperative ... The main objective of this study is to determine if a virtual reality headset can be tolerated during surgery under spinal anesthesia in patients aged 65 years ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11653539/

Intraoperative virtual reality for older patients undergoing total ... VR used as a non-pharmacological adjunct to regional and spinal anesthesia during TKA may reduce sedative requirements while maintaining patient satisfaction.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405456925000070

Beyond Anesthesia: A Mini Review of Virtual Reality as an ... This mini-review examines the role of VR as a distraction method during urological interventions under local or regional anesthesia in adults.

4. thelancet.com thelancet.com/journals/lansea/article/PIIS2772-3682(24)00087-8/fulltext

Multicenter, randomized, controlled comparative ... Virtual reality (VR) has been shown to reduce pain and anxiety during procedures, but there are no studies comparing it to sedation and a ...

5. researchprotocols.org researchprotocols.org/2024/1/e52649

Effectiveness of Virtual Reality in Reducing Perceived Pain ... The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12418640/

Effect of virtual reality on perioperative anxiety, stress and ... Virtual reality (VR) has shown promise as a nonpharmacological alternative to pharmaceutical pain relievers and anxiety medications in clinical ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08551-6

Intraoperative virtual reality for older patients undergoing total ... It has been found safe and effective in reducing pain and anxiety for inpatients and those with chronic pain, during minor procedures, as well ...